Quality Manager - Medical Device

PMT Corporation•Chanhassen, MN

About The Position

PMT Corporation, located in Chanhassen, Minnesota, is known for manufacturing and distributing high end, innovative products within the Orthopedic, Neurosurgery, and Plastic Surgery markets. PMT is hiring a Quality Manager to develop and implement quality practices where necessary. To enforce company’s compliance to the GMPs, ISO requirements and other requirements necessary of a medical device manufacture of safe and effective devices. To assist and train employees where necessary on the GMPs and to follow the established system. To apply good technical solutions and to ensure empirical evidence is documented per written procedures.

Requirements

Bachelor’s degree in related field of engineering, science, or regulatory affairs, or equivalent experience.
Strong attention to detail.
Minimum 5 years’ experience in medical device industry.
Experience working with quality system, ISO and quality assurance.
Excellent communication and time management skills.
Proficient in Microsoft Office Suite.

Responsibilities

Becomes personally skilled in all inspection and testing procedures.
Coordinates and conducts quality audits per the defined schedule.
Develops procedures and SOPs to control inspected and non-inspected product.
Assists in the development, maintenance and implementation of processes and procedures in accordance with regulatory requirements.
Implements procedures and SOPs for QA/QC and ISO audits of Receiving, Receiving Inspection, Inventory, Manufacturing, manufacturing test, In-process inspection, Final inspection, engineering, Pre-production, new product development, Customer Service, Training, Purchasing, Shipping, and Documentation as well as other departments that effect quality, GMPs and other regulatory requirements.
Monitors, maintains and assists with validation, sterilization, risk management and design activities.
Establishes that all manufacturing processes and procedures are in accordance with properly released documentation.
To assist in the resolution, documentation, customer responses of product complaints.
Coordinate efforts for external services (i.e. calibration, environmental testing, and standards) to perform tasks according to documented schedules.
Coordinate and assist in corrective and preventative action activities and solutions
Monitor and trend quality indicators to report to management and to provide early warning for quality related issuesall employees throughout all departments
Work with cross-functional teams to complete all assigned tasks